NICHD Director’s ReportCatherine Y. Spong, M.D.Acting Director, NICHD

Presentation Overview

• News from NIH

• News from NICHD

• Legislative and Budget Updates

• Questions

News from NIH

Dr. Diana Bianchi Named NICHD Director• Executive director of the Mother Infant

Research Institute • Vice chair for pediatric research at the

Floating Hospital for Children and Tufts Medical Center in Boston

• Natalie V. Zucker Professor of Pediatrics, and Obstetrics and Gynecology at Tufts University School of Medicine

• Start date: November 7, 2016

Dr. Joshua Gordon Named NIMH Director• Psychiatrist and neuroscientist

• Brain plasticity in mouse visual system• Disease mutations on behavior

• Associate Professor of Psychiatry at Columbia University Medical Center

• Research Psychiatrist at the New YorkState Psychiatric Institute

• Associate Director of Columbia University/New York State Psychiatric Institute Adult Psychiatry Residency Program

NIH Clinical Center

Over the last 15 months a number of changes occurred that will further strengthen NIH’s longstanding commitment to patients, staff, and to scientific excellence

Clinical Center Changes• ACD Working Group on the Clinical Center

(“The Red Team”) made recommendations on reducing risk and promoting patient safety at the NIH Clinical Center

• NIH has taken the following steps:• Established a Hospital Board• Established an NIH Office of Research Support and

Compliance• Retained two companies specializing in quality

assurance for manufacturing and compounding

Hospital Board Appointments

• Chairperson: Laura Forese, M.D., executive vice president and chief operating officer at New York-Presbyterian

• Executive Director: Lawrence Tabak, D.D.S., Ph.D., Principal Deputy Director, National Institutes of Health

• Ellen Berty• Beatrice Bowie• Ruth Brinkley, MSN/Adm.• Brig. Gen. James Burks,

MBA, MMAOS• Carolyn Clancy, M.D.• Jeanette Erickson, RN, DNP• Paul O'Neill, M.P.A.

• Peter Pronovost, M.D., Ph.D.• Richard Shannon, M.D.• Reed Tuckson, M.D.

Hospital Board Members

Clinical Center Hospital Board• Inaugural NIH Clinical Center Research Hospital

Board Meeting held on July 15, 2016• Public meeting, available on videocast.nih.gov • First meeting included welcome and NIH

Director's overview, discussed Clinical Center leadership feedback, governance structure, and Chief Executive Officer characteristics

• Upcoming meetings:• October 21, 2016 • January 13, 2017

New Clinical Center Appointments• New Chief of Pharmacy, Dr.

Majid Tanas recruited from the Oregon Health and Science University

• Dr. Andrew Griffith, NIDCD Scientific Director, will oversee the NIH Office of Research Support and Compliance (ORSC), while a permanent director is recruited

New Clinical Center Appointments

• Valerie Bonham, J.D., named the deputy of ORSC

• Dr. Bruce Burnett, an expert in regulatory, quality, and preclinical Good Laboratory Practices (GLP) support, joined us from Duke University for a year to help with the ORSC

Other Clinical Center Staff Changes• John Gallin, M.D., NIH Associate Director for

Clinical Research (ADCR) and Chief Scientific Officer (CSO) for the Clinical Center

• oversee the scientific review process for all clinical protocols conducted within the NIH Intramural Program;

• help set priorities for clinical research across ICs at the Clinical Center;

• oversee the independent research programs of Clinical Center investigators and clinical research training at NIH

• oversee the strategic planning process for Intramural Clinical Research and develop strategic partnership

Precision Medicine Initiative® (PMI) Cohort Program

PMI: Initial Awards for Program Infrastructure•Data and Research Support Center – $15.1M

• Vanderbilt University Medical Center, with the Broad Institute and Verily

•Biobank – $14.8M• Mayo Clinic

•Participant Technologies Center – $20M• Scripps Research Institute, with Vibrent Health

•Health Care Provider Organizations (HPOs)• Regional Medical Centers, Community Health Centers

(Federally Qualified Health Centers), VA Medical Centers

All figures are estimates and represent funding for FY16, as part of multi-year awards. As recorded in NIH RePORT, 9/19/16.

HPOs: Regional Medical CentersIllinois Precision Medicine Consortium: Northwestern, University of Chicago, and University of Illinois at Chicago($5.3M)

University of Pittsburgh($4.2M)

University of Arizona and Banner Health($4M)

Columbia, Cornell, Harlem Hospital, and NewYork-Presbyterian($4.5 M)

Initial sites selected July 2016More to come in Sept. 2016

All figures are estimates and represent funding for FY16, as part of multi-year awards. As recorded in NIH RePORT, 9/19/16.

HPOs: Federally Qualified Health Center Pilot Sites

Hudson River Health CarePeekskill, NY

Cherokee Health SystemsKnoxville, TN

Eau Claire Cooperative Health CenterColumbia, SC

San YsidroHealth CenterSan Ysidro, CA

Jackson-Hinds Comprehensive Health CenterJackson, MS

Community Health Center, Inc.Middletown, CT

Initial sites selected July 2016More to come

Pilot program to develop community health center approaches for enrolling underserved populations; a collaboration with HRSA and the MITRE Corporation

Survey Shows Broad Support for the PMI Cohort Program• Public opinion survey conducted by the Foundation for

the NIH: 2,601 responses analyzed• 79% supported the program after reading short

description• 54% said they would definitely or probably participate if

asked—not predictive of enrollment #’s, but encouraging

• Little variability among demographic groups• Most important incentive for participation: learning

about one’s health informationKaufman DJ, Baker R, Milner LC, Devaney S, Hudson KL (2016) A Survey of U.S Adults’ Opinions about Conduct of a Nationwide Precision Medicine Initiative® Cohort Study of Genes and Environment. PLoS ONE 11(8): e0160461. doi:10.1371/journal.pone.0160461

ECHO/IDeA States Pediatric Clinical Trials Network

• IDeA States Pediatric Clinical Trials Network grants reviewed at August Council session

• Dr. Matthew Gillman will speak today about the Environmental Influences on Child Health Outcomes (ECHO) program

• Will have some exciting news to share about the for IDeA States Pediatric Clinical Trials Network

News from NICHD

Funding the Best Science• Flexibility for discretionary funding

• Identify priorities more clearly• Be more strategic about our investments:

• Mechanisms• Number of awards/investigators• Large programs• Acceptance of large grants• > $1 Million reviews• Participation in Funding Opportunity

Announcements

Then2016 Payline

Now2016 Payline↑R01 at 10%-tile

Improving the NICHD Payline

* Not K99 which then/now at 22PS

• R01 at 9%-tile• R01 New Investigator

at 12th%• R03 & R21 at 9th%• K’s at 12PS*• F30 at 26PS• F31 at 12th%• F32 at 20th%

↑ R01 New Investigator at 13th%

↑ R03 & R21 at 10th%↑ K’s at 14PS*↑ F30 at 29PS↑ F31 at 19th%↑ F32 at 26th%

Branch Funding Priorities Announced

Zika Virus Activities

• Grant Awards• ZIP Cohort Study• NICHD Outreach and

Communications• Current Statistics for Pregnant

Women and Pregnancy Outcomes

• Workshop Focused on the Children

PAR-16-106 - Rapid Assessment of ZikaVirus (ZIKV) Complications (R21)

• Open March 20, 2016 and expires on March 1, 2019

• Applications accepted on a rolling basis, beginning on April 20, 2016

Provides an expedited (rapid) funding mechanism for research on Zikavirus (ZIKV) and its complications given the urgent need to determine whether ZIKV infection causes microcephaly and other congenital abnormalities in babies and the potential rapid spread of ZIKV to the United States.

NIH Funds Zika Virus Study Involving U.S. Olympic Team

• Researchers will monitor potential Zika virus exposure among a subset of athletes, coaches and other U.S. Olympic Committee (USOC) staff attending the 2016 Summer Olympics and Paralympics in Brazil

• Aims to improve understanding of how the virus persists in the body and to identify potential factors thatinfluence the course of infection

NICHD Intramural Zika Awards

• Drs. Leonid Chernomordik and Joshua Zimmerberg, for their grant, Zika Virus Entry into the Cells: Assays and Mechanisms

• Dr. Leonid Margolis for his grant Pathogenesis and Transmission of Zika Virus in Human Tissue ex vivo

Zika in Infants and Pregnancy (ZIP) Cohort Study • Multi-site, multi-country prospective observational

cohort study • Primary Goals:

• Risk of Zika during pregnancy• Outcomes of Zika during pregnancy-both symptomatic

and asymptomatic infection• Fetal and infant outcomes• Assess the effect of timing of infection and potential

confounders (e.g. environmental factors, co-infections) on outcomes

ZIP Cohort Study• 10,000 women in the first trimester• Women followed monthly until delivery and then

6 weeks postpartum• Infants evaluated within 48 hours of birth and at

3, 6, and 12 months of age• Standardized protocol, centralized data collection

diagnostic tests (reagents and procedures), diagnostic algorithm

• Supported by NICHD, NIAID, NIEHS,Fundacao Oswaldo Cruz-Fiocruz

ZIP Cohort Study Sites

Open for enrollment: Puerto Rico sites- 2/2Brazil sites- 2/4

ZIP Cohort Study UpdateSite Name StatusZ01: Brazil - Pernambuco Anticipated start date October, 2016

Z02: Brazil - Salvador Enrolling

Z04: Brazil - Sao Paulo Enrolling

Z04: Brazil - Rio de Janeiro Enrolling

Z05: Colombia – Cali and Medellin Anticipated start date October 2016

Z06: Guatemala - Amatitlan and Mazatenango Anticipated start date September 2016

Z07: Nicaragua - Managua Anticipated start date November 2016

Z08: Puerto Rico - North Karst EnrollingZ09: Puerto Rico - San Juan Enrolling

Zika Update:NIH Advisory Committee to the Director -

• Update on the Zika outbreak and NIH’s activities, including the ZIP cohort study

• http://acd.od.nih.gov/presentations/062016_Spong.pdf

American Museum of Natural History’s SciCafe Special Event: Zika: What You Need to Know

Panel talk available online: https://www.youtube.com/watch?v=SJodZY4bPZcSusan Perkins, Ian Lipkin, Cathy Spong, and Jay Varma

Reddit Science: Ask Me Anything

Pregnant Women with Zika Virus Infection

www.cdc.gov

Pregnancy Outcomes: Zika Virus

www.cdc.gov

Workshop Focused on the Children• September 22-23, 2016 in Bethesda, Maryland• Define the evidence to understand how prenatal Zika

virus infection affects child development and to identify strategies for evaluation, management, and treatment and outline future research needs

• Information: https://palladianpartners.cvent.com/ZIKV2016• Webcast also available:

• Day 1: https://videocast.nih.gov/summary.asp?live=19498&bhcp=1• Day 2: https://videocast.nih.gov/summary.asp?live=19502&bhcp=1

Photo attribution: Agência Brasil

NIH Rehabilitation Plan

Launch of NIH Medical Rehabilitation Plan

• The Research Plan on Rehabilitation was published on September 14, 2016 with the concurrence of 17 participating Institutes and Centers

• The launch of the plan occurred as part of a White House Office of Disability Policy event on September 15, 2016

• Communication roll out included Capitol Hill and interested organizations

NIH Medical Rehabilitation Plan• Includes six areas of research priorities created

through consultation with the National Advisory Board for Medical Rehabilitation Research (NABMRR), the NIH Medical Rehabilitation Coordinating Committee, and public input garnered through formal requests and a town hall meeting

• Rehabilitation through the Lifespan• Family and Community• Technology and Device Development• Research Design and Methodology• Translational Research• Building Research Capacity

• Performance will be monitored and reported in the May meeting of the NABMRR

Staff Updates

Dr. Jean Flagg-Newton

Acting Director, OHEretiring at the end of September

• National Institute of General Medical Sciences

• Fogarty International Center • Deputy Director and Chief of the Office of

Research in the National Center on Minority Health and Health Disparities

• Implemented the Center’s first Centers of Excellence Program and the Research Endowment Program

NIH Director’s Awards

• Lisa Kaeser, Caroline Signore, Robert Tamburro, and David Weinberg for the NCS Redirection/ECHO Working Group

• Eugene Hayunga, Lisa Kaeser, Rosalina Bray, and Sarah Glavin for the NIH-Wide Strategic Plan Working Group

• Michael Weinrich and James Coulombefor the Stimulating Peripheral Activity to Relieve Conditions (SPARC) Working Group

• Yan Li and Chi Hon Lee for the Virtual-Reality Systems Group

• Brenda Hanning for exemplary performance while demonstrating significant leadership, skill and ability in serving as a mentor

Legislative and Budget Updates

Legislative Briefings• On June 14 Dr. Alison Cernich

presented at the Women andTraumatic Brain Injury Congressional Briefing

• On June 28 The Friends of the NICHD held a briefing, “Research from A to Zika: How What Happens During Pregnancy Influences Child Health” Spong, Sheffield, Colombo,Cernich presented

Freedom of Information Act Law• S. 337 (Cornyn R-TX) signed by the President on

June 30 and became Public Law 114-185• Provides the public access to information under

the Freedom of Information Act (FOIA), including the right to appeal agencies’ decision to withhold information

• Requires Federal agencies to make information disclosable under FOIA available to the public in an electronic, publicly accessible format

• Agencies must make the “raw statistical data” used in each report available in the same format

Introduced: National Defense Authorization Act (NDAA)• S. 2943 (McCain R-AR), NDAA must be reauthorized by Congress –

two provisions of interest added to this year’s bill:• Text of S. 800 (Kirk, R-IL), Enhancing the Stature and Visibility of

Medical Rehabilitation Research at NIH Act • Amend the Public Health Service Act to improve, coordinate and

enhance rehabilitation research at the NIH and incorporate The World Health Organization’s definition of medical rehabilitation research

• Directs the NCMRR Director to develop a research plan, updated every 5 years and to identify existing resources to support research priorities

• Another provision would provide coverage of medically necessary food and vitamins for digestive and inherited metabolic disorders under the TRICARE program (first time explicit coverage mandated)

• NDAA will be voted on after elections

Introduced: National Pediatric Centers • S. 3115 (Wicker R-MS), the Pediatric Research

Improvement Act of 2016, require NIH to establish a national pediatric research network

• The NIH Director would work with appropriate ICs to establish such a network

• Similar provision included in the H.R. 6, or “Cures” bill that passed the House in July 2015

• The National Pediatric Research Network Act only allowed, did not mandate, the NIH to create this network.

Budget Update

• Will likely be no budget as we begin Fiscal Year 2017 on October 1st

• Likely to have a Continuing Resolution through December 9th

(with flat funding)

Questions?